1. Field of the Invention
This invention is related to exercise devices for rehabilitating and strengthening the muscles of the pelvic floor, particularly the collective group of muscles referred to as the female pubococcygeal and related perineal musculature.
2. Description of the Related Art
Disorders that involve the pelvic area (bladder, pelvic floor muscle, rectum and uterus) are of great concern to women and health care providers as well. The pubococcygeal muscle or pelvic floor muscle is responsible for holding all the pelvic organs within the pelvic cavity. The pelvic floor muscle consists of a deep muscle layer and a superficial muscle layer that work together to keep the pelvic organs healthy and in good working order. The muscle is suspended like a hammock at the base of the pelvis and wraps around the vagina and rectum generally in an over-under figure “8” pattern.
The lower pelvic muscles may become damaged or weakened through childbirth, lack of use, aging, or as the collateral result of surgical procedures. One of the symptoms related to a weakening of these muscles is urinary incontinence. Other pelvic disorders include chronic pelvic pain and vulvodynia (pelvic muscle dysfunction) that are sometimes experienced by young adult women. These disorders are caused by involuntary contractions (spasms) of the levator ani and perineal muscles. This condition, sometimes referred to as vaginismus or pelvic floor tension myalgia, is accompanied by difficult and painful penetration of the vagina.
Various exercise devices have been developed in an attempt to restore the pelvic floor muscles, with the specific goal of strengthening the muscles that surround the urethra to overcome urinary incontinence in women. The field of pelvic muscle rehabilitation in the treatment of urinary incontinence has its origins in the pioneering work of Dr. Arnold H. Kegel and his perineometer invention disclosed in U.S. Pat. No. 2,507,858, issued to Dr. Kegel in 1950.
Dr. Kegel's perineometer was the first instrument to use biofeedback to objectively assess pelvic muscle strength, both in the physician's office, and in daily at-home use by the patient. His perineometer consisted of an inflatable vaginal probe connected by an air tube to an air pressure gauge whose dial was calibrated in millimeters of mercury. The device enabled a woman (and her physician) to observe the strength and duration of her pelvic muscle contractions in order to learn effective exercise technique.
Pelvic floor exercises increase the flow of blood to this region, as well as creating strength and tone to the muscle itself, which helps with healthy tissue renewal. Like any other muscle within the body, the pelvic musculature benefits from pelvic floor exercises and toning on a regular basis. In keeping with the acknowledged therapeutic effects of this technique, improvements to perineometer devices continue to be proposed, in which the biofeedback features are enhanced. For example, U.S. Pat. No. 6,063,045 issued to Wax et al. in 2001 shows a vaginal probe that includes an internal pressure sensor that is connected to an external display device via electrical conductors for monitoring the contraction of pelvic floor muscles. Biofeedback patterns formed on the display device guide the patient through an exercise routine.
More recently, an improved perineometer probe was disclosed in U.S. Published Patent Application No. 20060036188, entitled “Perineometer with Wireless Biofeedback,” published Feb. 16, 2005 by Craig A. Hoffman, Gerry M. Hoffman and Michael John England. That invention features a self-contained perineometer probe for intravaginal use that communicates a wireless biofeedback signal to a small hand-held controller and display unit. The display unit provides audible and visual biofeedback signals that allow the patient to monitor her exercise efforts as self-directed or according to a prescribed training protocol, and optionally as prompted by a pre-programmed routine contained in the display unit.
Contemporary pelvic muscle training instruments are now incorporating vibrators for applying vibratory stimulation during exercise routines. Vibratory stimulation is known to have therapeutic and beneficial effects on human body tissue. Vibration at low frequencies applied to tissue increases blood circulation due to the increase in capillary dilation. The increased blood flow increases the consumption of oxygen and nutrients by muscles and improves the regeneration process. The result is improved muscle tone, elasticity and contractile capacity.
An example of vibratory stimulation is given in U.S. Pat. No. 6,905,471 to Leivseth et al., which discloses a pelvic exercise trainer in the form of a probe having a pressure sensor, a vibrator and a microprocessor circuit connected to the sensor and vibrator. The contraction of the pelvic floor muscles is repeated at intervals, and the force applied by pelvic floor muscles at each contraction is measured and compared with the highest previously registered value, which is stored in memory. The vibrator is activated at each contraction only if the contraction force attains or exceeds the most recent registered value, and only for as long as that relationship is maintained, e.g., the sensed pelvic contraction force attains or exceeds at least 80% of the last registered value.
U.S. Pat. No. 5,782,745 to Benderev discloses a pelvic exercise trainer in the form of a probe having a vibrator assembly and mechanical means for extending and retracting the assembly for the purpose of stretching the pelvic muscles. The probe is operable in a minimum profile, rest mode configuration where it exerts only base-line pressure, and operable in an extended profile, exercise mode configuration where it is capable of exerting higher pressure. A timer controls transitions between the operating modes. The vibrator assembly is operable only when the probe is in the extended configuration (exercise mode).
Notwithstanding the progress made by conventional pelvic exercise devices, there is a continuing interest in providing an improved biofeedback probe that can apply internal vibration therapy and is effective for rehabilitating and strengthening the muscles of the pelvic floor, particularly the collective group of muscles referred to as the female pubococcygeal and related perineal musculature. There is a further need for a biofeedback probe that can apply internal vibration therapy and is effective for use by women who are experiencing painful pelvic spasms (pelvic floor tension myalgia), as an aid for training pelvic muscle relaxation techniques.